Key messages
Due to a lack of robust evidence, it is not clear whether positive pressure therapy works to improve the symptoms of people with Ménière's disease. We did not find any information on whether this treatment may cause any harm.
Larger, well-conducted studies are needed in order to identify whether positive pressure therapy may be effective, and make sure that there are no harmful effects of treatment.
Further work also needs to be done to find out how best to measure the symptoms of people with Ménière's disease, in order to assess whether treatments are beneficial or not. This should include the development of a 'core outcome set' - a list of things that should be measured in all studies on Ménière's disease.
What is Ménière's disease?
Ménière's disease is a condition that affects the inner ear. It causes repeated attacks of dizziness or vertigo (a spinning sensation), together with hearing problems, tinnitus (ringing, humming or buzzing noises in the ears) and a feeling of fullness or pressure in the ear. It usually affects adults, and starts in middle age.
How is Ménière's disease treated?
Oral medications (tablets) and lifestyle interventions are often used as the first treatment for Ménière's disease. If these do not work to control the symptoms, then other treatments may be tried. This includes positive pressure therapy, which involves placing a tube into the ear that is attached to a pump. The pump generates waves of pressure, which may help to reduce some symptoms of Ménière's disease. Typically, people use the pump for about five minutes at a time, up to three times per day.
What did we want to find out?
We wanted to find out:
- whether there was evidence that positive pressure therapy works to reduce the symptoms of Ménière's disease;
- whether positive pressure therapy might cause any harm.
What did we do?
We searched for studies that compared positive pressure therapy to either no treatment or sham (placebo) treatment.
What did we find?
We found three studies, which included a total of 238 people. They lasted for a maximum of four months, so we do not have any information about longer-term effects of this treatment.
It is unclear whether positive pressure therapy makes any difference to symptoms of vertigo in the short term (up to four months).
We do not have any information on potential harms of the treatment (serious adverse effects) as none of the studies reported this.
What are the limitations of the evidence?
We have very little confidence in the evidence because the studies conducted were very small and had problems in their conduct, which means that the results may be unreliable. Larger, well-conducted studies are needed to try and work out whether positive pressure therapy is effective.
How up-to-date is this evidence?
This evidence is up-to-date to September 2022.
The evidence for positive pressure therapy for Ménière's disease is very uncertain. There are few RCTs that compare this intervention to placebo or no treatment, and the evidence that is currently available from these studies is of low or very low certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.
Ménière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. It is often treated with medication, but different interventions are sometimes used. Positive pressure therapy is a treatment that creates small pressure pulses, generated by a pump that is attached to tubing placed in the ear canal. It is typically used for a few minutes, several times per day. The underlying cause of Ménière's disease is unknown, as is the way in which this treatment may work. The efficacy of this intervention at preventing vertigo attacks, and their associated symptoms, is currently unclear.
To evaluate the benefits and harms of positive pressure therapy versus placebo or no treatment in people with Ménière's disease.
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL; Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.
We included randomised controlled trials (RCTs) and quasi-RCTs in adults with a diagnosis of Ménière's disease comparing positive pressure therapy with either placebo or no treatment. We excluded studies with follow-up of less than three months.
We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome.
We included three studies with a total of 238 participants, all of which compared positive pressure using the Meniett device to sham treatment. The duration of follow-up was a maximum of four months.
Improvement in vertigo
A single study assessed whether participants had an improvement in the frequency of their vertigo whilst using positive pressure therapy, therefore we are unable to draw meaningful conclusions from the results.
Change in vertigo
Only one study reported on the change in vertigo symptoms using a global score (at 3 to < 6 months), so we are again unable to draw meaningful conclusions from the numerical results. All three studies reported on the change in the frequency of vertigo. The summary effect showed that people receiving positive pressure therapy had, on average, 0.84 fewer days per month affected by vertigo (95% confidence interval from 2.12 days fewer to 0.45 days more; 3 studies; 202 participants). However, the evidence on the change in vertigo frequency was of very low certainty, therefore there is great uncertainty in this estimate.
Serious adverse events
None of the included studies provided information on the number of people who experienced serious adverse events. It is unclear whether this is because no adverse events occurred, or whether they were not assessed and reported.